# K961051: Universal Total Wrist System (Modification)

- Pathway: 510(k) (Traditional)
- Applicant: Kinetikos Medical, Inc.
- Decided: Jun 6, 1996 after 87 days
- Product code: JWJ (Prosthesis, Wrist, 3 Part Metal-Plastic-Metal Articulation, Semi-Constrained)
- Device class: 2
- Regulation: 21 CFR 888.3800
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
14 later devices descend from it; 3 cite it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Protek Meuli Wrist: named in the summary without a submission number
- (no number) Howmedica AMC Wrist: named in the summary without a submission number
- (no number) Depuy Bi-Axial Wrist: named in the summary without a submission number

## Most influential descendants
- K020554: Modification to Universal Total Wrist System (2002), 10 descendants of its own
- K031203: Biax a.F. Wrist/Biax Advanced Fixation Wrist (2003), 8 descendants of its own
- K030037: Universal Total Wrist System (2003), 8 descendants of its own
- K042032: Maestro Total Wrist (2004), 7 descendants of its own
- K021859: Wrist Implant (2002), 4 descendants of its own

## Indications for use
The KMI Umiversal Total Wrist™ System is indicated for mtractable pam resulting from traumatic arthritis, osteo anhritis, rheumatoid arthritis, trauma induced osteo arthritis of the radial / Carpal joint. To replace functionality of the joint due to defonmity or elements stated above.

Source page: https://510kreport.com/device/K961051
Methodology: https://510kreport.com/methodology